(324 days)
The cCeLL - In vivo is an optic scanner probe placed in direct contact with tissue to create images of the internal microstructure of tissues and is indicated for use with indocyanine green (ICG) for fluorescence imaging as an aid in the visualization of vessels (micro- and macro-vasculature) blood flow in the cerebrovasculature before, during or after cranial diagnostic and therapeutic procedures, such as tumor biopsy and resection.
The cCeLL - In vivo is used to provide real-time endoscopic images of near-infrared (NIR) indocyanine green (ICG) dye fluorescence during minimally invasive, neurosurgery in adults.
The overall system includes a 6 mm Pixection ICG/NIR Endoscope (0°) for use in neurosurgery, a light source for emission of NIR illumination, a photo-multiplier tube capable of capturing NIR imaging, and a sterile probe sheath intended for maintaining a sterile barrier between the subject device and the patient. The cCeLL - In vivo can be used with any medical grade high definition (HD) monitor with a DVI-D or RGB input. The patient contacting components contact tissue or bone with a duration of less than 24 hours.
The provided text describes the cCeLL - In vivo device and its performance testing to demonstrate substantial equivalence to a predicate device. However, it does not include specific quantitative acceptance criteria or a dedicated study demonstrating the device meets those criteria in the typical sense of showing numerical thresholds for performance. Instead, the performance testing focuses on equivalence to a predicate device.
Here's an analysis of the provided information:
Acceptance Criteria and Reported Device Performance
The document describes various performance tests conducted to demonstrate the substantial equivalence of the cCeLL - In vivo device to its predicate. The "acceptance criteria" are implied to be achieving performance comparable to or equivalent to the predicate device, or meeting recognized safety and design specifications. The reported "device performance" is consistently "PASS" for all tests, indicating that the device met these implicit criteria of equivalence or specification conformance.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Image Sensitivity Analysis | Ability to visualize cerebral microstructures and vascular systems, including tumor tissue, surrounding normal tissue, and blood vessels using clinically relevant ICG concentrations. | PASS |
| Image Comparison Analysis | Visualize vessels of various sizes and changes in blood flow with image quality comparable to the predicate device. | PASS |
| Detection Linearity | Equivalent performance to the predicate device in capturing fluorescence intensity. | PASS |
| Geometric Distortion | Equivalent performance to the predicate device regarding geometric distortion. | PASS |
| Dynamic Range | Equivalent performance to the predicate device in gradation performance across its dynamic range. | PASS |
| Illumination & Detection Uniformity | Equivalent performance to the predicate device in illumination and detection uniformity (average intensity of fluorescent dots, illumination uniformity). | PASS |
| SNR & Sensitivity | Equivalent performance to the predicate device in signal-to-noise ratio (SNR) and sensitivity. | PASS |
| Video Latency | Equivalent performance to the predicate device in dynamic vision capability (initialization and stoppage of motion on screen). | PASS |
| Sterile Probe Sheath Tear Resistance | Withstand forces greater than those expected during clinical use for breaking strength at different joint interfaces on aged samples. | PASS |
| Electrical Safety / EMC | Conformity to IEC 60601-1:2005 + A1:2012 + A2:2021 and IEC 60601-1-2:2014 + A1:2020. | PASS |
| Software / Cybersecurity (Enhanced Level) | Conformity to FDA's "Content of Premarket Submissions for Device Software Functions" (June 14, 2023) and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, Postmarket Management of Cybersecurity in Medical Devices". | PASS |
| Biocompatibility | Biocompatibility of patient-contacting components (Sterile Probe Sheath) according to FDA's guidance and ISO 10993-1 for various endpoints (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Material medicated pyrogenicity, Hemocompatibility (indirect), Neurotoxicity). | PASS |
| Sterility / Shelf Life | Sterilization and shelf-life testing demonstrated the device is and can remain sterile and functional for the documented shelf life, conforming to ISO 11135:2014 + Amd1:2018, ASTM F1980-21, and ISO 11607–1:2019. | PASS |
Study Details for Performance Testing:
The document does not detail a single comprehensive "study" but rather a series of "Performance Testing" activities.
-
Sample size used for the test set and the data provenance:
- For "Image Sensitivity Analysis" and "Image Comparison Analysis," a "small animal model" was used. The exact number of animals is not specified.
- For other tests like Detection Linearity, Geometric Distortion, Dynamic Range, Illumination & Detection Uniformity, SNR & Sensitivity, and Video Latency, the tests were conducted using the subject and predicate devices, likely in a laboratory setting, without specific mention of "samples" in a patient data context.
- Data provenance is not explicitly stated as retrospective or prospective, or country of origin for the animal model. Given the context of equivalence testing against a predicate device, it is likely that these were controlled laboratory/pre-clinical tests.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the "Image Comparison Analysis," the results state: "as assessed across users with a range of experience." This implies human assessment, but the number of experts, their specific qualifications (e.g., radiologist with X years of experience), and how their input established ground truth are not specified.
- For all other tests, no experts were mentioned for establishing ground truth; the "ground truth" was likely defined by established physical properties or engineering measurements (e.g., optical power, brightness, tear resistance force).
-
Adjudication method for the test set:
- The document does not specify any adjudication method (e.g., 2+1, 3+1, none). For the "Image Comparison Analysis" where "users with a range of experience" assessed images, the method of combining their assessments or resolving discrepancies is not provided.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The document describes performance testing for substantial equivalence, not a comparative effectiveness study involving human readers with and without AI assistance. The device is a medical imaging device, but the testing focuses on its technical performance and equivalence to a predicate, not on improving human reader performance.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device is described as an "optic scanner probe" and a "medical fluorescence imaging device." The tests described are primarily focused on the intrinsic technical performance of this imaging device (e.g., image sensitivity, detection linearity, dynamic range, SNR, video latency). While "Image Comparison Analysis" involved "users," most tests, particularly the quantitative ones, appear to be standalone algorithm/device performance tests. The device itself is an imaging tool, not one that implies an "algorithm only" component separate from the imaging hardware.
-
The type of ground truth used:
- For "Image Sensitivity Analysis" and "Image Comparison Analysis," the ground truth was inferred from the "visualization of cerebral microstructures and vascular systems" in a small animal model, which represents a biological/physiological ground truth.
- For other engineering-focused tests (Detection Linearity, Geometric Distortion, Dynamic Range, Illumination & Detection Uniformity, SNR & Sensitivity, Video Latency, Sterile Probe Sheath Tear Resistance, Electrical Safety / EMC), the ground truth would be based on physical measurements and established standards/specifications.
- For Biocompatibility and Sterility/Shelf Life, the ground truth is adherence to validated international standards and protocols.
-
The sample size for the training set:
- The document does not provide any information regarding a "training set" or "sample size for the training set." This suggests the device (cCeLL - In vivo) is an imaging system, likely based on established optical and fluorescence imaging principles, and not necessarily an AI/machine learning product that requires a distinct training dataset in the typical sense for its core functionality.
-
How the ground truth for the training set was established:
- Since no training set information is provided, this question is not applicable based on the given text.
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).